There are thousands of individuals across the country who have filed lawsuits over the past decade alleging severe complications from hernia mesh surgery. In fact, lawsuits claiming hernia mesh injuries have already resulted in at least one multi-million dollar verdict and one settlement worth $184 million. Notwithstanding, new lawsuits continue to be filed.

What is Hernia Mesh?

Hernia mesh is a medical device used in hernia surgeries that provides additional support to repair damaged or weakened tissue due to the hernia. Studies are split on the success of hernia mesh: some show using mesh leads to less hernia recurrences while others found additional complications are more common when mesh is used. When a hernia occurs the intestines, fatty tissue or abdominal organ breaks through a weakened area in the surrounding connective tissue or muscle. While the most common area for a hernia to occur is at the abdominal wall, they can also happen in the inner or outer groin, belly button, at an incision or scar site, or along the diaphragm. Although a physician may choose to monitor a hernia at first, surgery is the only way to repair the damage caused by a hernia. In fact, it is estimated that more than one million hernia repairs happen each year in the United States. Hernias are also a medical condition that have a high recurrence rate. According to a study published in the Journal of the American Medical Association (JAMA) in 2014, hernia mesh devices result in a lower chance of a having a second or subsequent hernia than simply stitching closed the torn tissue. The reason for the fact that hernias are less common a subsequent time with this method is that the surgical mesh strengthens the torn or weakened tissues while stitches, in and of themselves, do not.

Common Hernia Mesh Complications

The United States Food & Drug Administration has analyzed scientific research and literature as well as its own adverse data to categorize likely complications from hernia mesh that patients may experience. The most common complications that have resulted from hernia mesh repairs include: infection, chronic pain, hernia recurrence, bowel obstruction, adhesion, and contraction. Other complications include autoimmune reactions to mesh, abnormal connections between organs, mesh migration and rejection, organ performations, bleeding, fluid build up at the surgery site, nerve damage, and tenderness at the implant site.

According to a study published in JAMA Surgery, mesh complications can occur up to five years after a procedure is performed. The results were presented at the 2016 Clinical Congress of the American College of Surgeons and found the rate of hernia mesh complications increased over a five-year time span. Out of a total of 3,242 participants studied, as many as 1,050 required abdominal surgery after the initial procedure. The study’s authors noted the extent of the benefits and risks of hernia mesh repair surgery is not known because of the limited trial data available on the subject. Part of the reason for limited data, according to the authors, is the FDA’s streamlined 510(k) premarket notification clearance process for hernia mesh medical devices. This process does not mandate detailed case studies or clinical trials to prove the product’s effectiveness or safety before it is approved for the marketplace.

Alternatives to Hernia Mesh Surgery

Previously, doctors often took a “watchful waiting” approach for patients who had hernias but showed no symptoms. Once hernia symptoms presented themselves, surgery would be sought. Today, however, the most common recommendation is that patients with hernias undergo surgery as soon as possible regardless of whether or not symptoms are present. While most hernia surgeries involve mesh, there are alternatives available. In fact, about 10 percent of hernia repair surgeries in the United States are performed without mesh. There are generally five techniques that serve as alternatives to hernia repair techniques:

Bassini repair: known as a tension repair because it places tension on muscle tissue around the hernia, this technique is primarily used today in developing countries;

McVay/Cooper’s ligament: an improvement on the tension technique, this surgery sutures tissue to the Cooper’s ligament and has shown to be suitable for larger hernia repairs

Shouldice repair: a more complicated tension repair technique, the surgery requires cutting through three different layers of muscle and connective tissue and then individually stitched closed overlapping on the previous layer;

Descarda repair: a tension-free procedure, involving suturing a strip of the patient’s own muscle to another muscle and the inguinal ligament; an

Guarnieri repair: another tension-free technique, this surgery can be performed with or without mesh. It overlaps the same muscle involved in the Descarda repair in a double-breast fashion.

Medical Device Litigation

Hundreds of thousands of Americans have used medical devices to improve their health and well-being, only to suffer temporary or permanent injuries due to defects in the products. Sometimes these injuries can be the basis for a successful products liability claim, such as the complications resulting from hernia mesh surgery. Defective product liability claims generally based on one of three legal theories: manufacturing defects, design defects, or marketing defects.

Manufacturing defects: this includes medical devices that were not properly assembled at the manufacturing facility or any point between the factory and where the consumer received or purchased the medical device;

Design defects: in this case although the product was manufactured in perfect harmony with the design, the design itself is unreasonably dangerous and results in harm;

Marketing defect: when a product is marketed improperly this means that the recommendation, warning (or lack thereof), or instructions regarding the product was inadequate or inaccurate or just completely omitted.

In a products liability case, there are several potential defendants who can be named in the lawsuit. This is because products liability law allows for financial responsibility for harm caused by a product to fall on any person or entity that was part of the product’s “chain of distribution.” The “chain of distribution” is the path that the product took from its inception to the manufacturer to the consumer. Parties that may be named as defendants in a product liability medical device claim include the manufacturer, testing laboratory, physician, hospital or clinic, and retail supplier.

Hernia Mesh Repair Attorneys

If you or someone you know has been injured as a result of hernia mesh repair surgery, contact the skilled dangerous medical device attorneys at the Roger Ghai Law Offices. These skilled lawyers ill aggressively fighting on your behalf and seek out the compensation to which you are entitled. Click here today to schedule your initial case evaluation.

Hernia repair is a common surgical intervention in the United States. Indeed, it is estimated that has many as 350,000 hernia surgeries are performed in America every year. In a majority of these surgeries doctors use mesh implants to improve damaged or weakened abdominal tissue. The reason for the use of meshes is that studies show they reduce the likelihood of hernia recurrence. Meshes have also been associated, however, with painful and serious medical complications as a result of the surgeries. A study published in 2016 by Science Daily revealed the rate of medical complications in patients who had hernia mesh implants is higher than those who did have this medical device implanted.

Most Troublesome Hernia Meshes

More than a decade ago the Food & Drug Administration (FDA) released the first in a series of recalls that involved Kugel Mesh hernia repair patches manufactured by C.R. Bard, a national healthcare manufacturer. Research showed a part of the plastic mesh patch device had a tendency of breaking resulting in bowel perforations. Perforations in the bowels cause painful and life-threatening medical complications. As a result of all the issues with the product C.R. Bard agreed to the biggest hernia mesh settlement to date – in the amount of $184 million to over 3,000 individuals claiming significant harm as a result of the mesh product.

Kugel mesh is not the only hernia repair medical device to cause medical issues in patients who have undergone implant surgery. Other mesh devices causing medical problems and facing multiple pending lawsuits. For example, Atricum C-Qur reportedly causes several issues including failing to incorporate into the body, severe inflammation and infections, opening of the surgery site weeks or even months after the surgery, adhering to the patient’s bowel making it more difficult to remove if there are complications, as well as severe scar tissue. Atrium C-Qur is different from other meshes in that it has a fish oil coating.

Likewise, in 2016 Johnson & Johnson’s withdrew its Ethicon PhysioMesh from the market after an unusually large number of problems with the device were reported by two large hernia registries in Europe. The recall, however, was not before thousands of patients had undergone implant surgery in the United States. Complications reported by patients include severe scar tissue or adhesions, migration of the mesh device, and bowel obstruction.

When a Hernia Requires Surgery

It is standard treatment for any type of femoral and inguinal hernia to treat the condition surgically. While most hernias are not complicated medical conditions, surgery is still commonly recommended especially when the condition is a recent diagnosis. Complications with the hernia – such as an incarcerated hernia or bowel obstruction – will likely need immediate surgical intervention. There are two types of hernia surgery methods: open procedure or laparoscopic repair. Because both procedures have similar complication rates, physicians do not necessarily prefer one over the other. Laparoscopic surgery – often referred to as minimally invasive surgery – is performed with the assistance of a video camera and numerous thin instruments. In a laparoscopic surgery the doctor is unable to see directly into the patient as he or she would during a traditional large incision open surgery. Accordingly, laparoscopic procedures cause less trauma on the abdomen but requires the use of a mesh. Inguinal and femoral hernias are often repaired laparoscopically unless the patient had prior surgery in the area (such as a prostatectomy, hysterectomy, or cesarean section).

Why Use Hernia Meshes?

Surgeons often use hernia meshes because using the medical device during the repair does not put tension on the tissue and, thus, reduces the likelihood of a hernia recurrence. Some studies reveal half of all hernia surgery repairs without the use of a mesh fail compared to the 20 percent of repair failures when a hernia mesh is used. Unless a patient has sepsis or an active infection, surgeons typically use hernia meshes.

There are two types of hernia meshes: synthetic and biologic tissue. The latter are made from human or animal tissue that has been washed to remove all cellular debris but leaves connective tissues in place. The former are made from polytetrafluoroethylene or polypropylene – the same compound materials that caused medical complications in the transvaginal mesh lawsuits. Complications including mesh migration and erosion are not uncommon in these products. While these meshes have been used since the late 1950s, polypropylene is not fit for implantation in humans.

FDA Continues Approving Hernia Meshes

Even though several types of hernia mesh products, made by different manufacturers, are causing medical complications in patients, the U.S. Food & Drug Administration continues to approve these products. The FDA does so through a premarket notification clearance process known as 510(k), which allows medical device manufacturers to avoid rigorous premarket safety testing that is required for many other types of medical devices trying to get on the market. Under the 510(k) approval process, manufacturers can put new medical devices on the market with much less scrutiny by claiming the product is similar to a medical device that is already on the market. Not surprisingly, medical device manufacturers continue to aggressively market hernia meshes despite growing complaints by consumers.

Intentional misrepresentation of the quality and safety of the hernia mesh device;

Negligent design of the hernia mesh;

Negligent marketing of an unsafe hernia mesh product; and

Intentionally, knowingly, and recklessly keeping information about the hernia mesh device from the public.

More than 19 different hernia mesh products and at least four manufacturers are involved in the current litigation over hernia mesh complications. If you or someone you care about has suffered medical complications from the implantation of a hernia mesh contact the skilled medical device attorneys at the Roger Ghai Law Offices. This law firm has years of experience representing the injured and will fight for the monetary compensation you deserve.

The United States Food & Drug Administration (FDA) continues to approve hernia mesh products, even though several thousands have reported injuries and some of these products have shown to be defective. More than 100,000 hernia meshes are implanted annually in America. Unfortunately, many of the most dangerous mesh products are still available on the market are yet to be recalled by the FDA. Symptoms and injuries that are commonly caused by defective hernia meshes include bowel obstructions and severe infections. Other symptoms include pain, adhesion, perforation, and recurrence of hernias.

Hernia Mesh Complications

The cause of hernia mesh complications can vary depending on the product itself. Generally, many hernia mesh products contain a specific type of plastic known as polypropylene. While polypropylene is the same material used in most pelvic mesh and bladder strings, it is also used to make non-medical products such as soda bottles and fishing lines. This material is commonly used because it is inexpensive.

There are several instances when a mesh is required to repair a hernia to alleviate the pain an individual is enduring. Indeed, the larger the hernia, the more likely a mesh is needed to repair the injury. That being said, when considering a hernia repair surgery, there are more than 50 mesh products from which to choose from numerous manufacturers that use a wide range of materials to create their product. These alternate materials include plastics, gels and even pigskins. Moreover, some hernias are easier to repair without surgically inserting a mesh. For example, an inguinal hernia is typically smaller than other types of hernias and can be repaired by a skilled surgeon. The use of hernia meshes in these types of hernias has resulted in thousands of patients developing and suffering from disabling pain.

Types of Hernias

A hernia is a bulging of an organ or tissue through an abnormal opening. Typically, a hernia involves the intestines or the stomach. There are more than 200,00 hernia cases per year. While some who have a hernia are asymptomatic the general symptoms include pain, swelling, or a bulge. Males are generally more affected by hernias than women and the most commonly ages of people who suffer from a hernia are 40 years and older.

There are several types of hernias, which are named after where the injury occurred, including:

Umbilical: near or at the bellybutton;

Inguinal: in the groin area;

Incisional: occurring at an old surgical incision;

Recurrent: happening at a previous hernia site;

Bilateral: appearing at both the right and left sides; and

Femoral: located high in the thigh area.

Hernia Repairs

There are several alternatives to hernia mesh when repairing a hernia for an individual suffering from this condition. These include shouldice repair, McVay repair, Bassini repair and desarda repair. Shouldice repair involves a surgeon performing only a two-layer suture using the patient’s fascia and tendon. A fascia is a thin sheath of fibrous tissue enclosing a muscle or other organ. A McVay repair, on the other hand, requires the abdominal tendons be sutured (or sewn) to the inguinal ligament. A Bassini repair involves a suture of the inguinal hernia preserving the spermatic cord. Finally, a desarda repair is a suture only repair, using numerous layers of fascia.

Before hernia meshes were used to repair hernias, surgeons typically used the shouldice technique on patients. This hernia reparation technique can trace its roots back to the Shouldice Hospital in Ontario, Canada. The technique is still highly favored today at this hospital. Part of the reason is that the shouldice technique has maintained a 99.5 percent success rate on primary inguinal hernia repairs for the past 70 years. It is not uncommon for a shouldice repair to be performed with local anesthetics, sutures, pain medication and a sedative.

When a Mesh is Not Necessary

As discussed above, not all hernia injuries require surgical mesh implantation. Moreover, there are some instances when a mesh should not be used at all. For example, smaller hernias such as those caused by laparoscopic surgery generally do not require mesh to repair. In fact, these smaller hernia injuries can often be fixed with sutures performed by an experienced surgeon. One of the issues with hernias is that they are difficult to fix permanently – there is a high rate of hernia recurrence both for those who have undergone suture or mesh repairs. The difference between the two is that when sutures fail and the hernia returns, a surgeon can merely attempt to re-stitch the hernia. When a hernia mesh fails and the hernia returns, there are often more complications that come with the recurrence. This is because the hernia is often much larger after a mesh failure. Furthermore, because abdominal tissue and muscle typically adheres to the mesh these must be removed along with the mesh after a failure.

Hernia Mesh Lawsuits

Manufacturers of hernia mesh products have funded research that has shown results that the use of hernia meshes showed a lower rate of hernia recurrence than other hernia repair surgeries. These studies have turned out to be inaccurate, however, partly because the length of time during which patients were monitored after the mesh implantation was insufficient. Some victims have developed hernia mesh complications 10 to 15 years after the surgery, despite an absorbable hernia mesh supposedly being able to remain in the body indefinitely. These latent injuries that reveal symptoms so many years later are not captured by these manufacturers’ studies.

Hernia Mesh Complication Attorneys

Patients who have been forced to submit to revision surgery because of hernia mesh complications may be entitled to monetary compensation by way of a lawsuit against the product’s manufacturers. A successful personal injury hernia mesh surgery may recover damages for medical bills, lost wages, as well as pain and suffering. And although there have not been many settlements for hernia mesh injuries yet, similar surgical meshes (like transvaginal mesh) have resulted in multi-million dollar verdicts.

The Law Offices Of Roger Ghai has years of experience representing injured victims and will fight to obtain the monetary compensation you deserve as a result of your hernia mesh injuries. We will push for the best possible settlement for you and your loved ones. Click here today to schedule your initial case evaluation with one of our seasoned personal injury attorneys.